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FDA Approves OxyContin for Kids as Young as 11

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G

GK86

Homeland Security Fail
Link. I searched and didn't see a thread.

The U.S. Food and Drug Administration said it has approved the use of the painkiller OxyContin in children as young as 11, for severe pain that can’t be adequately treated with other medications.

An FDA spokesman said the agency granted the approval Thursday, after the drug’s manufacturer, Purdue Pharma LP, submitted clinical-trial data on the drug’s safety and efficacy in children. In a posting on its website, the FDA said it asked Purdue to perform the studies in children.

OxyContin is an extended-release version of oxycodone, a powerful opioid painkiller. Widespread use of opioids in recent decades has helped spark what public-health officials call an epidemic of painkiller abuse in the U.S., including soaring rates of overdose deaths.

In a question-and-answer posting on the FDA’s site, the head of the agency’s painkiller division stressed that OxyContin’s new pediatric approval “was not intended to expand or otherwise change the pattern of use of extended-release opioids in pediatric patients,” but to better inform prescribing that was already taking place in children. Doctors are allowed to prescribe medicines any way they see fit, including for uses not approved by the FDA, a practice known as off-label prescribing.

“Prior to this action, doctors had to rely on adult clinical data to shape their decision-making in treating pediatric patients,” Sharon Hertz, director of the FDA’s division of anesthesia, analgesia and addiction products, said in the posting. “This program was intended to fill a knowledge gap and provide experienced health care practitioners with the specific information they need to use OxyContin safely in pediatric patients.”

Purdue’s chief medical officer, Gail Cawkwell, said in an emailed statement: “For the first time, physicians prescribing OxyContin for patients 11 years and older who have already been receiving opioids will be guided by FDA-approved dosing and safety information.”

The FDA’s Dr. Hertz said Purdue’s 2010 reformulation of OxyContin made it more resistant to being crushed or dissolved “to discourage abuse by nasal or intravenous routes.” Doctors and public-health officials say many patients have nonetheless figured out ways to abuse the reformulated drug.

Purdue has said the drug’s reformulation is “expected to reduce abuse,” though abuse “is still possible.”

Dr. Hertz added that OxyContin’s new pediatric approval is similar to its approved use in adults: to manage “pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.” But she said unlike the adult indication, the pediatric indication stipulates that before a child can be prescribed OxyContin, he or she must already be taking and tolerating at least 20 mg of oxycodone a day.

“This way, the doctor knows that their patient tolerates and responds appropriately to opioids,” she said.

Pediatric patients in Purdue’s study were prescribed OxyContin after severe trauma, or “after major spinal surgery or other types of major surgery,” Dr. Hertz said.

She added: “Parents and caregivers should follow all the usual safeguards for storing powerful medications when OxyContin is in their home. Briefly, make sure the medications are stored securely so young children never have direct access and also so that no one else in the household such as older children, siblings, friends, or other visitors have direct access. Also, it is extremely important to safely and properly dispose of unused OxyContin as soon as it is no longer needed.”

An FDA spokesman said as a condition of the new approval, the agency is requiring Purdue to submit data in the coming years characterizing how OxyContin is being used in children aged 17 and younger. He said the FDA will use this data “to examine how many OxyContin prescriptions are being dispensed, to what age groups, and at what doses; what proportion of pediatric patients receiving OxyContin are opioid tolerant; what types of health-care providers are prescribing OxyContin to children, for what indications, and for how long.”

The FDA is also requiring Purdue to submit reports for three years on adverse events involving the drug, including respiratory depression, accidental injury, overdose and misuse, he said.
Click to expand...
 
H

Hugstable

Banned
What the fuck how is something like this even a consideration. Please don't do this, do hurt this kids lives by letting them get ahold of this substance, this just sounds so bad.
 
M

Magilla

Banned
Yup this is horrible. I would much rather children be in pain than receive much needed relief for chronic pain. Truly sickening.
 
2

2San

Member
Hugstable said:
What the fuck how is something like this even a consideration. Please don't do this, do hurt this kids lives by letting them get ahold of this substance, this just sounds so bad.
Click to expand...
Yes, kids can easily handle pain, which adults can't handle.

>_>
 
Sub_Level

Sub_Level

wants to fuck an Asian grill.
Good but

Briefly, make sure the medications are stored securely so young children never have direct access and also so that no one else in the household such as older children, siblings, friends, or other visitors have direct access.
Click to expand...

that's not nearly as much of a problem as the adults looking through the medicine cabinet to get high.
 
D

Deleted member 80556

Unconfirmed Member
after the drug’s manufacturer, Purdue Pharma LP, submitted clinical-trial data on the drug’s safety and efficacy in children.
Click to expand...

Hmm. Hope that an independent group also does a study on this. But since it's the only study there is on this, I cannot dispute it.
 
Grinchy

Grinchy

Banned
I hear they're giving methotrexate to kids with leukemia too. I can't fucking stand when kids get medications that they need.
 
M

M0nochromatic

Member
At a glance it may seem off, but if you read the article the rationale makes sense.

We can't just tell the kids suffering from severe daily pain to suck it up and deal with it.
 
entremet

entremet

Member
Looks the restrictions are pretty strict.

The kid must already be taking oxyconodone before Oxycontin could be prescribe.

The addiction aspect is a tricky one due to how the drugs work.

But if someone is in chronic pain, do we let them suffer?

It's not a perfect solution, but not every medical intervention is.
 
S

Siegcram

Member
But she said unlike the adult indication, the pediatric indication stipulates that before a child can be prescribed OxyContin, he or she must already be taking and tolerating at least 20 mg of oxycodone a day.
Click to expand...
This part is key here. That's not exactly commonplace for 11 year olds.
 
L

Littlefang

Member
How long before the parents start stealing the OxyContin from their kids? So awful for the kids with shitty parents. On the upside, at least the kids with good parents don't have to feel as much pain anymore!
 
J

Jaladinozozo

Banned
I would rather give a kid edible cannabis for pain, even my own, any day over oxycontin

Synthetic heroin being pushed by pharmaceuticals is a silent epidemic in the US no one talks about
 
M

Makai

Member
Envelope said:
How anyone can see this as anything but a good thing is beyond me
Click to expand...
This thread:

12861darenpatriot.jpg
Click to expand...
 
T

Tenck

Member
Oh look two people haven't read the OP so far.

Reminds me of some Gaf user and his mom hiding pain killers from his sister when she had surgery in her mouth. Some people just can't grasp there's legitimate uses for pain killers.
 
Amory

Amory

Member
Littlefang said:
How long before the parents start stealing the OxyContin from their kids? So awful for the kids with shitty parents. On the upside, at least the kids with good parents don't have to feel as much pain anymore!
Click to expand...

Seems like a weird reaction.

"Hey this thing is available that wasn't available we think it'll help sick kids"

"Yeah but think of the kids that...still won't get it! Because what if their parents steal it! Awful."

There's no real downside here
 
D

demon

I don't mean to alarm you but you have dogs on your face
Jaladinozozo said:
I would rather give a kid edible cannabis for pain, even my own, any day over oxycontin
Click to expand...

Yeah, creating more opiate addicts is never a good thing. We should be transitioning from opiates to cannabis for pain management. Doctors often don't know what the fuck they're doing when dealing with patients addicted to opiate painkillers and it's common that once an addicted patient is cut off they move on to heroin. In fact I believe it's the number one cause of heroin addiction, if not then one of the biggest reasons.

How anyone can see this as anything but a good thing is beyond me
Click to expand...
Because opiates are not effective at long-term pain management and it often leads to illegal and medically unsupervised opiate abuse as mentioned above.

It's easy to say "how dare you deprive these suffering kids of opiates" while ignoring the long-term significant damage it can do to them.
 
J

Jaladinozozo

Banned
Tenck said:
Oh look two people haven't read the OP so far.

Reminds me of some Gaf user and his mom hiding pain killers from his sister when she had surgery in her mouth. Some people just can't grasp there's legitimate uses for pain killers.
Click to expand...

For every legit user of a pain killer (lets be real here and just call it opiates) there's 12+ non legit that now have access because of that company/drug and out of those 12, 4-5 will overdose and 1-2 of those ODs will result in death.

The synthetic opiate industry has been a catastrophe and no one really talks about it

It didn't even exist 30 years ago and the world didn't end because Oxycontin and all its variants did not exist
 
A

Amir0x

Banned
Jaladinozozo said:
I would rather give a kid edible cannabis for pain, even my own, any day over oxycontin

Synthetic heroin being pushed by pharmaceuticals is a silent epidemic in the US no one talks about
Click to expand...

Many people who tried to smoke marijuana for certain extreme pain do not find it effective for their level of severe pain, whereas oxycodone works for them.

Yes, many people are overprescribed these medications. That's a problem with those doing the prescribing, not the medications that are there to do their job when properly utilized.

This is clearly for kids in agonizing pain who already need 20mg just to feel OK. This is the type of pain that is worst case senario for a kid that age. We should not be taking options off the table because we don't like the implications. Many people in this sort of pain will be dead long before they even can give a fuck about the long-term damage.

Jaladinozozo said:
For every legit user of a pain killer (lets be real here and just call it opiates) there's 12+ non legit that now have access because of that company/drug and out of those 12, 4-5 will overdose and 1-2 of those ODs will result in death.
Click to expand...

Oh is this an actual statistic? Is this a real number? Or did you just pull it out of your ass?
 
G

GJS

Member
Already regularly used in children off-licence/unlicensed, this is just the FDA asking the manufacturer to provide data and the FDA approving it as a licensed use.

Even if the FDA didn't get involved it would still be used.
 
F

Fenderputty

Banned
Tenck said:
Oh look two people haven't read the OP so far.

Reminds me of some Gaf user and his mom hiding pain killers from his sister when she had surgery in her mouth. Some people just can't grasp there's legitimate uses for pain killers.
Click to expand...

I remember this thread.

Jaladinozozo said:
For every legit user of a pain killer (lets be real here and just call it opiates) there's 12+ non legit that now have access because of that company/drug and out of those 12, 4-5 will overdose and 1-2 of those ODs will result in death.

The synthetic opiate industry has been a catastrophe and no one really talks about it

It didn't even exist 30 years ago and the world didn't end because Oxycontin and all its variants did not exist
Click to expand...

Citation needed.
 
H

HalfBakedProphet

Member
Jaladinozozo said:
I would rather give a kid edible cannabis for pain, even my own, any day over oxycontin

Synthetic heroin being pushed by pharmaceuticals is a silent epidemic in the US no one talks about
Click to expand...
there absolutely is a worthy discussion to be had involving opiate addiction and over prescription of pain killers in the US

This just isn't the thread to do it in
 
J

Jaladinozozo

Banned
Amir0x said:
Many people who tried to smoke marijuana for certain extreme pain do not find it effective for their level of severe pain, whereas oxycodone works for them.

Yes, many people are overprescribed these medications. That's a problem with those doing the prescribing, not the medications that are there to do their job when properly utilized.

This is clearly for kids in agonizing pain who already need 20mg just to feel OK. This is the type of pain that is worst case senario for a kid that age. We should not be taking options off the table because we don't like the implications. Many people in this sort of pain will be dead long before they even can give a fuck about the long-term damage.



Oh is this an actual statistic? Is this a real number? Or did you just pull it out of your ass?
Click to expand...

http://www.asam.org/docs/default-source/advocacy/opioid-addiction-disease-facts-figures.pdf

-46 Americans die each day from prescription opioid overdoses; two deaths an hour, 17,000 annually
-While illicit opioid heroin poisonings increased by 12.4% from 1999 to 2002, the number of prescription
opioid analgesic poisonings in the United States increased by 91.2% during that same time period
-Drug overdose was the leading cause of injury death in 2013, greater than car accidents and homicide
-In 2012, 259 million opioid pain medication prescriptions were written, enough for every adult in America to
have a bottle of pills
 
D

Deleted member 1159

Unconfirmed Member
As a teenager I suffered severe migraines for weeks on end that really could only be treated with opioids. Fuck everyone here saying this is a bad thing. You clearly don't know what you're talking about.
 
K

KHarvey16

Member
For those objecting, what alternative exists today for a child in severe chronic pain? I have no idea what the efficacy of cannabis is regarding severe chronic pain, but I know it is not a choice we can use right now to treat what's happening today.

So what should be done?
 
A

Amir0x

Banned
Jaladinozozo said:
It didn't even exist 30 years ago and the world didn't end because Oxycontin and all its variants did not exist
Click to expand...

This is so fucking ridiculous it's hilarious. The world didn't end even when a billion astonishing medical breakthroughs we've had in the 20th century and beyond didn't exist; doesn't say anything about how much utility those breakthroughs had.

Jaladinozozo said:
http://www.asam.org/docs/default-source/advocacy/opioid-addiction-disease-facts-figures.pdf

-46 Americans die each day from prescription opioid overdoses; two deaths an hour, 17,000 annually
-While illicit opioid heroin poisonings increased by 12.4% from 1999 to 2002, the number of prescription
opioid analgesic poisonings in the United States increased by 91.2% during that same time period
-Drug overdose was the leading cause of injury death in 2013, greater than car accidents and homicide
-In 2012, 259 million opioid pain medication prescriptions were written, enough for every adult in America to
have a bottle of pills
Click to expand...

so nothing to back up your statistic then?
 
entremet

entremet

Member
KHarvey16 said:
For those objecting, what alternative exists today for a child in severe chronic pain? I have no idea what the efficacy of cannabis is regarding severe chronic pain, but I know it is not a choice we can use right now to treat what's happening today.

So what should be done?
Click to expand...

Cannabis sucks for pervasive chronic pain. It's just not that powerful and of course the side effects--paranoia and such are concerning at higher doses.
 
J

Jaladinozozo

Banned
Btw 20MG of oxy is a fuckin megadose

If you have never taken opiates before 20mg of oxy will put you out, drooling and possibly throwing up for at least 12 hours of the day (this is for a 160 lb average male adult, image for a kid)

Edible cannabis high in CBD can produce equal pain relief with non of the addiction or side effects
 
J

Jaladinozozo

Banned
entrement said:
Cannabis sucks for pervasive chronic pain. It's just not that powerful and of course the side effects--paranoia and such are concerning at higher doses.
Click to expand...

This simply is not true, it's even been medically proven edible cannabis is actually better for both chronic/long term pain management than opiates
 
entremet

entremet

Member
Jaladinozozo said:
This simply is not true, it's even been medically proven edible cannabis is actually better for both chronic/long term pain management than opiates
Click to expand...

Do you have a study?

Also giving cannabis to developing brains--children's in this case--is seriously a bad idea.
 
A

Amir0x

Banned
Jaladinozozo said:
Btw 20MG of oxy is a fuckin megadose

If you have never taken opiates before 20mg of oxy will put you out, drooling and possibly throwing up for at least 12 hours of the day (this is for a 160 lb average male adult, image for a kid)

Edible cannabis high in CBD can produce equal pain relief with non of the addiction or side effects
Click to expand...

Again

+ source for the study you can provide that demonstrate it produces "equal pain relief" for long-term chronic pain
+ explanation for how we are going to provide that sort of pain relief even if it were true (it's not) in a country where it's illegal in most places
+ a link to your Doctor's degree.
 
R

rjinaz

Member
Thaedolus said:
As a teenager I suffered severe migraines for weeks on end that really could only be treated with opioids. Fuck everyone here saying this is a bad thing. You clearly don't know what you're talking about.
Click to expand...

Likely people that have never experienced intense pain, the kind of pain that makes you consider ending your life just to get it to stop.
 
J

Jaladinozozo

Banned
Amir0x said:
This is so fucking ridiculous it's hilarious. The world didn't end even when a billion astonishing medical breakthroughs we've had in the 20th century and beyond didn't exist; doesn't say anything about how much utility those breakthroughs had.



so nothing to back up your statistic then?
Click to expand...

Yea my numbers add up, do the math using those statistics.

Also - You think synthetic opiates are an astonishing medical breakthrough?
 
G

GJS

Member
Jaladinozozo said:
Btw 20MG of oxy is a fuckin megadose

If you have never taken opiates before 20mg of oxy will put you out, drooling and possibly throwing up for at least 12 hours of the day (this is for a 160 lb average male adult, image for a kid)

Edible cannabis high in CBD can produce equal pain relief with non of the addiction or side effects
Click to expand...

20mg of oxycodone spread across the day is the usual starting dose. (5mg four times day)
Sure if you take it all at once it might knock you off your feet, but you aren't supposed to take it all at once.

It's a relatively small dose in overall terms.

20mg oxycodone = approximately 30mg morphine

When you use a 20mg daily dose of oxycontin you are looking at 10mg twice daily. Which gives 0.8mg/hour over the day.
 
K

KHarvey16

Member
entrement said:
Cannabis sucks for pervasive chronic pain. It's just not that powerful and of course the side effects--paranoia and such are concerning at higher doses.
Click to expand...

That's what I suspected given how mild a drug cannabis is. It seems like the desire is to make it all things to all people.
 
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